Comparison of outcomes and required tools between transvenous extraction of pacemaker and implantable cardioverter defibrillator leads: Insight from single high-volume center experience.

INTRODUCTION: Reports of comparison with procedural outcomes for implantable cardioverter defibrillator (ICD) and pacemaker (PM) transvenous lead extraction (TLE) are old and limited. We sought to compare the safety, efficacy, and procedural properties of ICD and PM TLE and assess the impact of lead age. METHODS: The study cohort included all consecutive patients with ICD and PM TLE in the Cleveland Clinic Prospective TLE Registry between 2013 and 2022. Extraction success, complications, and failure employed the definitions described in the HRS 2017 TLE guidelines. RESULTS: A total of 885 ICD leads, a median implant duration of 8 (5-11) years in 810 patients, and 1352 PM leads of 7 (3-13) years in 807 patients were included. Procedural success rates in ICD patients were superior to those of PM in >20 years leads but similar in ≤20 years leads. In the PM group, the complete success rate of TLE decreased significantly according to the increase of lead age, but not in the ICD group. ICD TLE required more extraction tools compared with PM TLE but cases with older leads required non-laser sheath extraction tools in both groups. The most common injury site in major complication cases differed between ICD and PM TLE, although major complication rates showed no difference in both groups (2.7% vs. 1.6%, p = .12). CONCLUSION: The procedural success rate by TLE is greater for ICD patients than PM patients with leads >20 years old but requires more extraction tools. Common vascular complication sites and the impact of lead age on procedural outcomes and required tools differed between ICD and PM TLE.

Clinical response with adaptive CRT algorithm compared with CRT with echocardiography-optimized atrioventricular delay: a retrospective analysis of multicentre trials.

AIMS: Adaptive cardiac resynchronization therapy (aCRT) is a novel algorithm for CRT pacing that provides automatic ambulatory selection between synchronized left ventricular (LV) or bi-ventricular (BiV) pacing and optimization of atrioventricular (AV) and inter-ventricular (VV) delays based on periodic measurement of intrinsic conduction. We aimed to compare the clinical response between aCRT and standard CRT in historical trials. METHODS AND RESULTS: The treatment arm of the aCRT trial was compared with a pooled historical control (HC) derived from the CRT arms of four clinical trials (MIRACLE, MIRACLE ICD, PROSPECT, and InSync III Marquis) with respect to the proportion of patients who had an improved clinical composite score (CCS) at the 6-month follow-up. Patients in the HC underwent echocardiography-guided AV optimization after the implant. A propensity score model was used to adjust for 22 potential baseline confounders of the effect of CRT. Patients were stratified into quintiles according to the propensity score and the adjusted absolute treatment effect was obtained by averaging estimates across these quintiles. The propensity score model included 751 patients (aCRT: 266, historical trials: 485). The adjusted absolute difference in percent improved in CCS between the aCRT and HC arms was 11.9% [95% confidence interval (CI): 2.7-19.2%] favouring aCRT. The patients in the aCRT group were significantly more likely to have an improved CCS than the patients in the HC (odds ratio = 1.65, 95% CI: 1.1-2.5). CONCLUSION: The aCRT algorithm may be associated with additional improvement in clinical response compared with historical CRT with echocardiographic AV optimization.

Spontaneous dissociated firing from the pulmonary veins during ablation of paroxysmal atrial fibrillation: implications and impact on arrhythmia-free survival.

BACKGROUND: Following pulmonary vein isolation (PVI) for the treatment of paroxysmal atrial fibrillation (AF), spontaneous dissociated firing (DiFi) from the isolated veins may be observed. Little is known about the significance and prognostic implications of this phenomenon. We sought to determine the relationship between DiFi and ablation outcomes. METHODS: The study population consisted of 156 paroxysmal AF patients who underwent first time PVI and were found to have spontaneous DiFi from the pulmonary veins (PVs). Their outcomes were compared to a population of 156 propensity-matched controls from our prospectively maintained AF ablation data registry. RESULTS: DiFi was most frequently observed from the right superior PV and occurred in 89 patients (57.1%). After 24 months of follow-up, patients with DiFi had better success rates compared to those with silent veins after isolation (88.5% vs 75%, P = 0.002). The overall distribution of types of recurrent arrhythmia was similar between DiFi patients and their matched controls (P = NS). During repeat ablations, DiFi patients were less likely to have PV conduction recovery (60% vs 93.3%, P = 0.02). Importantly, none of the veins with DiFi during index procedures was found to have conduction recovery. CONCLUSION: In patients with paroxysmal AF undergoing ablation, DiFi from the PVs after their isolation was associated with improved ablation outcomes. It is possible that DiFi is an indicator of successful durable isolation of the PVs. The findings suggest that confirmation of exit block may be warranted to improve AF ablation outcomes.

Clinical predictors of incomplete coronary sinus lead removal during transvenous lead extraction in patients with cardiac resynchronization therapy.

BACKGROUND: Reports of coronary sinus (CS) lead removal include small studies with short implant durations. Procedural outcomes for mature CS leads removed with long duration implantation are unavailable. OBJECTIVE: The purpose of this study was to examine the safety, efficacy, and clinical predictors of incomplete CS lead removal by transvenous lead extraction (TLE) in a large long implant duration cardiac resynchronization therapy patient cohort. METHODS: Consecutive patients with cardiac resynchronization therapy devices in the Cleveland Clinic Prospective TLE Registry who had TLE between 2013 and 2022 were included in the analysis. RESULTS: CS leads (N = 231; implant duration 6.1 ± 4.0 years) removed from 226 patients were included, using powered sheaths for 137 leads (59.3%). Complete CS lead extraction success was achieved in 95.2% of leads (n = 220) and in 95.6% of patients (n = 216). Major complications occurred in 5 patients (2.2%). Patients who had the CS lead extracted first had significantly higher incomplete removal rates than when the other leads were first removed. Multivariable analysis showed that older CS lead age (odds ratio 1.35; 95% confidence interval 1.01-1.82; P = .03) and removal of the first CS lead (odds ratio 7.48; 95% confidence interval 1.02-54.95; P = .045) were independent predictors of incomplete CS lead removal. CONCLUSION: The complete and safe lead removal rate of long implant duration CS leads by TLE was 95%. However, CS lead age and the order in which leads were extracted were the independent predictors of incomplete CS lead removal. Therefore, before the CS lead is extracted, physicians should first extract the leads from the other chambers and use powered sheaths.

Catheter ablation of atrial fibrillation in elderly and very elderly patients: safety, outcomes, and quality of life.

BACKGROUND: Atrial fibrillation (AF) risk increases with age. We aim to assess the efficacy and safety of catheter ablation in the older population. METHODS: All patients undergoing AF ablation (2013-2021) at our institution were enrolled in a prospectively maintained registry. The primary endpoint was AF recurrence. Patients were divided into 3 groups: non-elderly (< 65 years), elderly (65-75 years), and very elderly (> 75 years). Patient surveys at baseline and during follow-up were used to calculate quality of life (QoL) metrics: the AF severity score as well as the AF burden. RESULTS: A total of 7020 patients were included (42% non-elderly, 42% elderly, and 16% very elderly). Periprocedural major complications were low (< 1.5%) and similar in all groups besides pericardial effusion which was more frequent with older age and similar between the elderly and very elderly. At 3 years, AF recurrence for persistent AF (PersAF) was highest in the very elderly group (48%), followed by the elderly group (42%), and was the lowest in the non-elderly group (36%). In paroxysmal AF (PAF), there was no difference in AF recurrence between the elderly and non-elderly, while the very elderly remained associated with a significantly increased risk. Multivariable Cox analysis confirmed these findings (PersAF; elderly: HR = 1.23, P = 0.003; very elderly: HR = 1.44, P < 0.001) (PAF; elderly: HR = 1.04, P = 0.62; very elderly: HR = 1.30, P = 0.01). Catheter ablation resulted in a significant improvement in quality of life, irrespective of age group. CONCLUSION: Catheter ablation in elderly and very elderly patients is safe, efficacious, and associated with QoL benefits. Overall, major complications were minimal and did not differ significantly between age groups, with the exception of pericardial effusions which were higher in the elderly and very elderly compared to non-elderly adults. Very elderly patients had a higher rate of AF recurrence when compared with elderly or non-elderly patients. Nevertheless, ablation resulted in a remarkable improvement in QoL and a reduction of AF burden and AF symptoms with a similar magnitude, irrespective of age.

Plasma B-type natriuretic peptide levels and recurrent arrhythmia after successful ablation of lone atrial fibrillation.

BACKGROUND: Plasma B-type natriuretic peptide (BNP) is abnormally elevated in patients with lone atrial fibrillation (AF). The exact significance and prognostic implications of this elevation have yet to be determined. Little is known about BNP in lone AF patients undergoing arrhythmia ablation. We sought to determine the relationship between BNP levels and the risk of recurrent arrhythmia after ablation of lone AF. METHODS AND RESULTS: We followed up 726 patients with lone AF undergoing first-time arrhythmia ablation. All had BNP levels measured on the day of ablation with of the point-of-care Triage Meter assay (Biosite Diagnostics, San Diego, CA). At baseline, factors associated with elevated BNP levels in multivariable linear regression analysis (with log BNP being the dependent variable) were older age (ß regression coefficient for +1-year change, 0.025; P<0.0001), longer duration of AF (ß for +1-year change, 0.031; P=0.01), nonparoxysmal AF (versus paroxysmal; ß, 0.52; P<0.0001), and larger left atrial size (ß for +1-cm(2) change, 0.040; P<0.0001). The BNP levels were strongly associated with arrhythmia recurrence in univariate- (hazard ratio for +1-log-BNP change, 2.32; 95% confidence interval, 2.11 to 2.74; P<0.001) and covariate- (hazard ratio for +1-log-BNP change, 2.13; 95% confidence interval, 2.06 to 2.38; P<0.001) adjusted Cox proportional hazards analysis. The covariate-adjusted hazard ratios for recurrent arrhythmia were 1.6, 2.7, 4.3, and 5.7 for the second, third, fourth, and fifth quintiles, respectively, compared with patients in the lowest quintile (P for trend across quintiles <0.001). CONCLUSIONS: B-type natriuretic peptide levels correlate with AF burden (chronicity, altered hemodynamics, and anatomic remodeling) in patients with lone AF and are strong predictors of recurrent arrhythmia after ablation. Elevated BNP levels may reflect increased cardiac chamber wall stress and/or intrinsic atrial disease, thus increasing the risk of arrhythmia recurrence.

Cardiac venous left ventricular lead removal and reimplantation following device infection: a large single-center experience.

BACKGROUND: Early series of biventricular device removal have contained mostly younger cardiac venous (CV) left ventricular leads and few have reported on rates of successful reimplantation. METHODS AND RESULTS: We performed a retrospective analysis of all patients referred to the Cleveland Clinic between February 2, 2001 and July 27, 2011 for removal of a biventricular device with a CV pacing lead for an infectious indication. A total of 173 patients were included. The median age of the CV leads was 22.3 months (interquartile range: 5.2-46.3 months). The complete procedural success rate for all leads was 97.7%, with the remaining 2.3% clinical successes. A total of 76.9% of CV leads were removed using simple traction alone with the remaining leads requiring the use of a laser-powered sheath. A total of 3.5% of leads required intervention (manual dissection or laser-powered dissection) within the coronary sinus (CS). Major complications occurred in 1.2% of patients. Minor complications occurred in 7.5% of patients, the majority of which were hematomas requiring drainage (6.9%). CV lead reimplantation was attempted in 107 patients of which 88 (82.8%) were successful. CONCLUSION: CV lead removal in patients with an infected biventricular device is associated with an extremely high procedural success rate and a low incidence of major complications. The use of a laser-powered sheath is necessary in roughly one-quarter of cases with a very small percentage requiring intervention within the CS. Reimplantation of CV leads is achievable in roughly 83% of patients, a figure lower than nationally quoted estimates for de novo implantations.

Atrial support pacing in heart failure: results from the multicenter PEGASUS CRT trial.

INTRODUCTION: Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population. This trial was designed to evaluate the effect of atrial support pacing among heart failure patients receiving a CRT defibrillator. METHODS AND RESULTS: PEGASUS CRT was a multicenter, 3-arm, randomized study. At 6 weeks, patients were randomized to DDD mode at a lower rate of 40 bpm (DDD-40; control arm), or one of the following 2 treatment arms: DDD-70, or DDDR-40. The primary endpoint was a clinical composite endpoint that included all-cause mortality, heart failure events, NYHA functional class, and patient global self-assessment. Subjects were classified as improved, unchanged, or worsened at 12 months. There were 1,433 patients randomized, of whom 66% were male, mean age was 67 ± 11 years, and mean left ventricular ejection fraction was 23 ± 7%. The average follow-up time was 10.5 ± 3.5 months and 1,309 patients contributed to the primary endpoint. No significant differences were observed in the composite endpoint between either of the 2 treatment arms compared to the control arm (P>0.05 for both comparisons). Additionally, there were no differences among the groups in mortality or heart failure events. CONCLUSION: In advanced heart failure patients treated with CRT, atrial support pacing did not improve clinical outcomes compared to atrial tracking. However, atrial pacing did not adversely affect mortality or heart failure events.

Pulmonary-vein isolation for atrial fibrillation in patients with heart failure.

BACKGROUND: Pulmonary-vein isolation is increasingly being used to treat atrial fibrillation in patients with heart failure. METHODS: In this prospective, multicenter clinical trial, we randomly assigned patients with symptomatic, drug-resistant atrial fibrillation, an ejection fraction of 40% or less, and New York Heart Association class II or III heart failure to undergo either pulmonary-vein isolation or atrioventricular-node ablation with biventricular pacing. All patients completed the Minnesota Living with Heart Failure questionnaire (scores range from 0 to 105, with a higher score indicating a worse quality of life) and underwent echocardiography and a 6-minute walk test (the composite primary end point). Over a 6-month period, patients were monitored for both symptomatic and asymptomatic episodes of atrial fibrillation. RESULTS: In all, 41 patients underwent pulmonary-vein isolation, and 40 underwent atrioventricular-node ablation with biventricular pacing; none were lost to follow-up at 6 months. The composite primary end point favored the group that underwent pulmonary-vein isolation, with an improved questionnaire score at 6 months (60, vs. 82 in the group that underwent atrioventricular-node ablation with biventricular pacing; P<0.001), a longer 6-minute-walk distance (340 m vs. 297 m, P<0.001), and a higher ejection fraction (35% vs. 28%, P<0.001). In the group that underwent pulmonary-vein isolation, 88% of patients receiving antiarrhythmic drugs and 71% of those not receiving such drugs were free of atrial fibrillation at 6 months. In the group that underwent pulmonary-vein isolation, pulmonary-vein stenosis developed in two patients, pericardial effusion in one, and pulmonary edema in another; in the group that underwent atrioventricular-node ablation with biventricular pacing, lead dislodgment was found in one patient and pneumothorax in another. CONCLUSIONS: Pulmonary-vein isolation was superior to atrioventricular-node ablation with biventricular pacing in patients with heart failure who had drug-refractory atrial fibrillation. (ClinicalTrials.gov number, NCT00599976.)

The impact of left ventricular size on response to cardiac resynchronization therapy.

UNLABELLED: Patients with nondilated (NDCM) or severely dilated cardiomyopathies (SDCM) have been underrepresented in clinical trials of cardiac resynchronization therapy (CRT). We examined changes in left ventricular ejection fraction (LVEF) and survival in patients with NDCM or SDCM compared with those with traditionally studied moderately dilated cardiomyopathy. METHODS: We evaluated 800 consecutive patients undergoing the original implantation of a biventricular pacemaker between January 2004 and August 2007. For inclusion, patients had a baseline and pre-CRT echocardiogram, an LVEF ≤40%, a US social security number, and New York Heart Association class II to IV symptoms on standard medical therapy. Patients with a follow-up echocardiogram >2 months after device implantation were included in an analysis of remodeling. Using multivariate models, the impact of baseline left ventricular end-diastolic diameter (LVEDD) on change in LVEF and all-cause mortality was assessed. RESULTS: A total of 668 patients met inclusion criteria and were included in the assessment of mortality. Four hundred seventy-one had an appropriately timed follow-up echocardiogram and were included in the analysis of remodeling. Patients in all 3 groups realized improvements in LVEF (%) after CRT as follows: NDCM (n = 137; LVEDD ≤5.5 cm) 10.0 ± 12.7, P < .001; moderately dilated cardiomyopathy (n = 233; LVEDD 5.6-6.9 cm) 8.2 ± 11.3, P < .001; and SDCM (n = 101; LVEDD ≥7.0 cm) 5.4 ± 9.4, P < .001. In multivariate analysis, baseline LVEDD was inversely associated with change in LVEF (parameter estimate -3.13 ± 0.56, P < .001) and directly associated with increased all-cause mortality (hazard ratio 1.25 [1.05-1.47] P = .01). CONCLUSION: Patients with NDCM and SDCM experience significant improvements in LVEF after CRT. The degree of baseline left ventricular dilatation before CRT is an important predictor of subsequent changes in LVEF and survival.

The QRS narrowing index predicts reverse left ventricular remodeling following cardiac resynchronization therapy.

BACKGROUND: The relationship between QRS narrowing and response to cardiac resynchronization therapy (CRT) has been controversial. OBJECTIVE: We sought to analyze the relationship between QRS narrowing and reverse remodeling in patients undergoing CRT, taking into account potential confounders including pre-CRT QRS duration and underlying QRS morphology. METHODS: We reviewed pre- and postimplant electrocardiograms and echocardiograms in a cohort of 233 patients undergoing the new implantation of a CRT device between December 2001 and September 2006. For inclusion in the final cohort, patients had New York Heart Association classes II-IV heart failure, left ventricular ejection fraction (LVEF) ≤ 40%, and QRS duration ≥120 ms. Response to CRT was defined as a reduction in left ventricular end-systolic volume (LVESV) of ≥10%. A multivariate model was constructed to determine the relationship between QRS change and response to CRT. RESULTS: Patients with QRS narrowing had significantly greater reductions in left ventricular end-diastolic volume (LVEDV) (mL) (-26.5 ± 52.5 vs -4.8 ± 44.0, P = 0.002) and LVESV (mL) (-34.0 ± 55.5 vs -9.9 ± 45.8, P = 0.002) and improvement in LVEF (%) (8.9 ± 12.8 vs 4.5 ± 9.0, P = 0.007) than patients without narrowing. In univariate analysis, female gender (P = 0.0002), percent QRS narrowing from baseline (P = 0.008), lack of nitrate (P≤0.0001) and antiarrhythmic medication use (P = 0.01), lack of a nonspecific intraventricular conduction delay (=0.02), nonischemic cardiomyopathy (P = 0.003), and lower pre-CRT LVEDV (P = 0.006) and LVESV [P = 0.01]) were associated with responders. In a multivariate model, QRS narrowing, indexed to the baseline QRS duration, remained strongly associated with response (odds ratio 0.08 [0.01-0.56], P = 0.01). CONCLUSIONS: After adjusting for potential confounders, QRS narrowing, indexed to baseline QRS duration, is associated with enhanced reverse ventricular remodeling following CRT.

QRS fragmentation is not associated with poor response to cardiac resynchronization therapy.

BACKGROUND: QRS fragmentation (fQRS) has been shown to be a marker of scar in patients with left ventricular dysfunction. Whether fQRS is associated with progressive left ventricular remodeling and increased mortality in patients receiving cardiac resynchronization therapy (CRT) is unclear. METHODS: We reviewed the preimplant and follow-up echocardiograms in 233 patients undergoing the new implantation of a CRT device between December 2001 and November 2006. Patients were included if they had a pre-CRT ECG with appropriate filter settings (filter 0.16-100 or 0.16-150 Hz, 25 mm/s, 10 mm/mV), a left ventricular ejection fraction (LVEF) ≤40%, and New York Heart Association class II-IV symptoms on standard medical therapy. The 12-lead electrocardiogram (ECG) was interpreted by two blinded reviewers for the presence of fQRS. Remodeling end points, including changes in LVEF and left ventricular end-diastolic (LVEDV) and systolic (LVESV) volumes, were compared between patients with and without contiguous fQRS, and an assessment of all-cause mortality was made. RESULTS: Two hundred thirty-two patients met inclusion criteria, of which 50 demonstrated fQRS in contiguous leads. There was no difference in improvement in LVEF (%) (7.9 ± 12.9 vs 6.8 ± 11.0, P = 0.60) or reduction in LVEDV (mL) (-30.1 ± 57.2 vs -15.7 ± 47.6) or LVESV (mL) (-33.7 ± 58.1 vs -22.7 ± 50.6, P = 0.40) between patients with and without contiguous fQRS. At a mean follow-up of 4.4 ± 1.9 years, there were a total of 89 deaths, 22 (44.0%) in patients with contiguous fQRS and 67 (36.8%) without (log rank P = 0.31). CONCLUSIONS: QRS fragmentation is not a predictor of progressive ventricular remodeling or mortality in heart failure patients undergoing CRT.

Cardiac resynchronization therapy in non-left bundle branch block morphologies.

INTRODUCTION: In select patients with systolic heart failure, cardiac resynchronization therapy (CRT) has been shown to improve quality of life, exercise capacity, ejection fraction (EF), and survival. Little is known about the response to CRT in patients with right bundle branch block (RBBB) or non-specific intraventricular conduction delay (IVCD) compared with traditionally studied patients with left bundle branch block (LBBB). METHODS: We assessed 542 consecutive patients presenting for the new implantation of a CRT device. Patients were placed into one of three groups based on the preimplantation electrocardiogram morphology: LBBB, RBBB, or IVCD. Patients with a narrow QRS or paced ventricular rhythm were excluded. The primary endpoint was long-term survival. Secondary endpoints were changes in EF, left ventricular end-diastolic and systolic diameter, mitral regurgitation, and New York Heart Association (NYHA) functional class. RESULTS: Three hundred and thirty-five patients met inclusion criteria of which 204 had LBBB, 38 RBBB, and 93 IVCD. There were 32 deaths in the LBBB group, 10 in the RBBB, and 27 in the IVCD group over a mean follow up of 3.4 +/- 1.2 years. In multivariate analysis, no mortality difference amongst the three groups was noted. Patients with LBBB had greater improvements in most echocardiographic endpoints and NYHA functional class than those with IVCD and RBBB. CONCLUSION: There is no difference in 3-year survival in patients undergoing CRT based on baseline native QRS morphology. Patients with RBBB and IVCD derive less reverse cardiac remodeling and symptomatic benefit from CRT compared with those with a native LBBB.

Ablation of Atrial Fibrillation Without Left Atrial Appendage Imaging in Patients Treated With Direct Oral Anticoagulants.

BACKGROUND: Many centers continue to routinely perform transesophageal echocardiograms before atrial fibrillation (AF) ablation procedures in patients treated with direct oral anticoagulants (DOACs). One study suggested that the procedures could be done without transesophageal echocardiogram but used intracardiac echocardiography imaging of the appendage from the right ventricular outflow. This study aimed to assess the safety of ablation for AF without transesophageal echocardiogram screening or intracardiac echocardiography imaging of the appendage in DOAC compliant patients. METHODS: All patients undergoing AF ablation at the Cleveland Clinic (2011-2018) were enrolled in a prospectively maintained data registry. All consecutive patients presenting with AF or atrial flutter on DOAC were included. Periprocedural thromboembolic complications were assessed. RESULTS: A total of 900 patients were included. Their median CHA2DS2-VASc score was 2 (interquartile range 1-3). All were on DOACs (333 rivaroxaban, 285 dabigatran, 281 apixaban, and 1 edoxaban). Thromboembolic complications occurred in 4 patients (0.3%): 2 ischemic strokes, 1 transient ischemic attack without residual deficit, and 1 splenic infarct; all with no further complications. Bleeding complications occurred in 5 patients (0.4%): 2 pericardial effusions (1 intraoperative, 1 after 30 days, both drained), 3 groin hematomas (1 of them due to needing heparin for venous thrombosis, none required interventions). No patients required emergent surgeries. CONCLUSIONS: In DOAC compliant patients who present for ablation in AF/atrial flutter, the procedures could be performed without transesophageal echocardiogram screening or intracardiac echocardiography imaging of the appendage; with low risk of complications.

Transvenous lead extraction in patients with prior extraction procedures: Procedural profiles and outcomes.

BACKGROUND: Subclinical venous injuries are common during transvenous lead extraction (TLE), but their implications for future TLE are unclear. Little is known about whether a prior TLE adds risk or complexity to subsequent extraction procedures. OBJECTIVE: The purpose of this study was to assess procedural profiles and outcomes of TLE based on whether patients had prior extraction procedures. METHODS: All 3258 consecutive patients undergoing TLE at the Cleveland Clinic (1996-2012) were included. Procedural profiles and outcomes were determined. RESULTS: Of 3258 TLEs, 198 had prior TLE. Median number of leads in place was 2 in both groups, but patients with prior TLE were more likely to have defibrillator leads (47% vs 41%; P = .08) and more likely to be pacemaker-dependent (32% vs 25%; P = .02). The age of oldest lead (median 2134 vs 1902 days; P = .4) and combined age of leads (median 2948 vs 2676 days; P = .6) were comparable. Procedures were longer in those with prior TLE (166 ± 79 minutes vs 149 ± 74 minutes; P = .004) with comparable fluoroscopy times (median 13 vs 11 minutes; P = .07), and successful extraction was more likely to require specialized tools (88% vs 81%; P = .006) with higher likelihood of rescue femoral workstation (12% vs 4%; P <.0001). Clinical success rates were comparable in those with prior TLE (99.5% vs 98.9%; P = .8) with similar major (3.0% vs 1.9%; P = .3) and minor (3.0% vs 3.7%; P = .8) complication rates. CONCLUSION: Extraction procedures were more challenging in patients with prior TLE compared to those without prior TLE but with excellent success and low complication rates.

Clinical Outcomes and Characteristics With Dofetilide in Atrial Fibrillation Patients Considered for Implantable Cardioverter-Defibrillator.

BACKGROUND: Dofetilide is one of the only anti-arrhythmic agents approved for atrial fibrillation (AF) in patients with reduced left ventricular ejection fraction (LVEF). However, postapproval data and safety outcomes are limited. In this study, we assessed the incidence and predictors of LVEF improvement, safety, and outcomes in patients with AF with LVEF ≤35% without prior implantable cardioverter defibrillator, cardiac resynchronization therapy, or AF ablation. METHODS: An analysis of 168 consecutive patients from 2007 to 2016 was performed. Incidences of adverse events, drug continuation, implantable cardioverter defibrillator and cardiac resynchronization therapy implantation, LVEF improvement (>35%) and recovery (≥50%), AF recurrence, and AF ablation were determined. Multivariable regression analysis to identify predictors of LVEF improvement/recovery was performed. RESULTS: The mean age was 64±12 years. Dofetilide was discontinued before hospital discharge in 46 (27%) because of QT prolongation (14%), torsades de pointe or polymorphic ventricular tachycardia/fibrillation (6% [sustained 3%, nonsustained 3%]), ineffectiveness (5%), or other causes (3%). At 1 year, 43% remained on dofetilide. Freedom from AF was 42% at 1 year, and 40% underwent future AF ablation. LVEF recovered (≥50%) in 45% and improved to >35% in 73%. Predictors of LVEF improvement included presence of AF during echocardiogram (odds ratio, 4.22 [95% CI, 1.71-10.4], P=0.002), coronary artery disease (odds ratio, 0.35 [95% CI, 0.16-0.79], P=0.01), left atrial diameter (odds ratio, 0.52 per 1 cm increase [95% CI, 0.30-0.90], P=0.01), and LVEF (odds ratio, per 1% increase, 1.09 [95% CI, 1.02-1.16], P=0.006). The C statistic was 0.78. CONCLUSIONS: In patients with LVEF ≤35%, who are potential implantable cardioverter defibrillator candidates, treated with dofetilide as an initial anti-arrhythmic strategy for AF, drug discontinuation rates were high, and many underwent future AF ablation. However, most patients had improvement in LVEF, obviating the need for primary prevention implantable cardioverter defibrillator.

Catheter Ablation in Patients With Cardiogenic Shock and Refractory Ventricular Tachycardia.

BACKGROUND: There is paucity of data regarding radiofrequency ablation for ventricular tachycardia (VT) in patients with cardiogenic shock and concomitant VT refractory to antiarrhythmic drugs on mechanical support. METHODS: Patients undergoing VT ablation at our center were enrolled in a prospectively maintained registry and screened for the current study (2010-2017). RESULTS: All 21 consecutive patients with cardiogenic shock and concomitant refractory ventricular arrhythmia undergoing bailout ablation due to inability to wean off mechanical support were included. Median age was 61 years, 86% were men, median left ventricular ejection fraction was 20%, 81% had ischemic cardiomyopathy, and PAINESD score was 18±5. The type of mechanical support in place before the procedure was intra-aortic balloon pump in 14 patients (67%), Impella CP in 2, extracorporeal membrane oxygenation in 2, extracorporeal membrane oxygenation and intra-aortic balloon pump in 2, and extracorporeal membrane oxygenation and Impella CP in 1. Endocardial voltage maps showed myocardial scar in 19 patients (90%). The clinical VTs were inducible in 13 patients (62%), whereas 6 patients had premature ventricular contraction-induced ventricular fibrillation/VT (29%), and VT could not be induced in 2 patients (9%). Activation mapping was possible in all 13 with inducible clinical VTs. Substrate modification was performed in 15 patients with scar (79%). After ablation and scar modification, the arrhythmia was noninducible in 19 patients (91%). Seventeen (81%) were eventually weaned off mechanical support successfully, but 6 (29%) died during the index admission from persistent cardiogenic shock. Patients who had ventricular arrhythmia and cardiogenic shock on presentation had a trend toward lower in-hospital mortality compared with those who presented with cardiogenic shock and later developed ventricular arrhythmia. CONCLUSIONS: Bailout ablation for refractory ventricular arrhythmia in cardiogenic shock allowed successful weaning from mechanical support in a large proportion of patients. Mortality remains high, but the majority of patients were discharged home and survived beyond 1 year.

Experience with the hansen robotic system for atrial fibrillation ablation--lessons learned and techniques modified: Hansen in the real world.

INTRODUCTION: The Hansen robotic system has only recently been used in the United States for catheter ablation procedures in humans. Atrial fibrillation (AF) ablation may be performed utilizing this system. We report our management of complications with early experience of this system. METHODS AND RESULTS: All 71 patients in whom the system was utilized were included. In all patients, a 2-operator technique was to be employed; one operator manipulates the ablation catheter via the robot and the other manipulates the circular mapping and intracardiac echocardiogram catheters. There was no procedure-related mortality. All vascular complications occurred in the first 25 procedures performed. There were 6 intraoperative procedural-related complications. These included significant vascular complications (n = 4), one of whom required iliac vein stenting, and 2 cardiac tamponade (one related to a pop-phenomenon)-successfully treated by pericardiocentesis. Early complications (n = 3) were 1 tamponade several hours post-procedure, 1 vascular complication, and 1 pericarditis. Late complications included 5 patients with severe pulmonary vein stenosis (all in first 27 patients) and 1 patient with gastroparesis. All complications were successfully managed without persistent morbidity and occurred earlier in our experience. This led to specific alterations in our vascular access and ablation techniques. These include the use of a longer 14 Fr sheath, through which the robotic sheath is more safely advanced. The choice of ablation catheter and titration of power, particularly when the catheter has a perpendicular orientation to the atrial wall, is also important. CONCLUSIONS: The suggested modifications may make the system easier to use with the potential to reduce complications.

The magnitude of reverse remodelling irrespective of aetiology predicts outcome of heart failure patients treated with cardiac resynchronization therapy.

AIMS: We assessed the relationship between cardiac resynchronization therapy (CRT)-induced reverse remodelling and mortality during a long-term follow-up in a prospective observational study. METHODS AND RESULTS: We analyzed data from a prospective registry including 398 consecutive patients who underwent CRT between September 1998 and September 2007. Left ventricular ejection fraction (LVEF) was assessed before CRT and in the period between 3 and 6 months following implant. All-cause mortality, urgent transplantation and implantation of left ventricular assist device were all considered relevant events. A total of 398 (179 non-ischaemic and 219 ischaemic) patients were analysed. Overall, the increase of LVEF was statistically significant and was computed with 7.0 points (95% CI 5.8-8.3, P < 0.001). Non-ischaemic patients had a larger increase [9.2 points (95% CI 7.0-11.1), P < 0.001] of their LVEF from baseline, when compared with the ischaemic group. The median duration of follow-up was 4.4 years. The cumulative incidence of all events at the end of the 96 months period of follow-up was 55% and it was 34% (95% CI 29-40) at 5 years. At the multivariable analysis of the event-free survival, aetiology lost its predictive value (HR 0.92, P = 0.47), while a change in LVEF >or=6 points still significantly decreased the risk of event during the follow-up (HR 0.30, P = 0.001). CONCLUSION: Reverse remodelling measured by LVEF after 3 months is a good predictor of long-term outcome. Patients with an increase in LVEF >or=6 points have an excellent event-free survival approaching 66% at 5 years of follow-up.